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It is resignation time. The time has come to move on from the present job. The time to reach out for a writing pad and draft out th

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

e resignation letter. So what do you do? Should you give a list of reasons why you are leaving? Should you feel guilty about leavin

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

g your team and the organization in a lurch? Should you give a list of reasons about how badly you were treated? Should you get sen

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

timental and list out all that you gained and how wonderful it was?

The ideal resignation letter is the one that is the shortest,

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

to the point. Give the date of resignation and enquire when the organization could let you go. The more detail you go into the more

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

explanations follow. Giving reasons for leaving could be open to all kinds of misinterpretations, so a simple “I would like to res

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ign from the post of xx as on this date” would do. There is no need to feel guilty about leaving the organization in a lurch becaus

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

it is a professional relationship and just as you have a right to your career opportunities, the organization also has a right to

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

throw you out when it does not need you. So there is really no need to feel guilt. But yes, if the job requires that you train some

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

one else or to finish something that you have begun, it is only fair that you complete that part. If you are quitting due to some b

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ad experiences, it is not a great idea to put that on paper because then the organization might get wary about your motives and sta

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ll the process. Just as well there is no need to get all sentimental about the organization because if for some reason you have to

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

sue the employer, your letter will make it rather difficult to prove that you had a difficult time in the organization.

All these

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

issues point out in one direction. When it comes to the resignation letter, keep it simple and straight, courteous and formal. Add

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

touch of gratitude because it always pays to be grateful. And most importantly keep it in mind that you may have to seek a referen

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ce from your ex-employers at some point of time in the future.

A sample resignation letter would look something like this.

Name

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

r> Address
Phone Number
E-mail

Date

Recipient's name
Company name
Address

Dear Ms/Mr. X:

Please treat this

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

letter as my formal notice of resignation from Y. I would like to be relieved from my duties as Z in a week’s time. I hope that th

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

e notice period is sufficient and I would like to know whether I would be required to complete any particular jobs within this peri

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

od.

I would also like to thank you very much for giving me the opportunity to work here.

Sincerely,

Signature

(Name, title)

cc

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Common defects from forming operations are discussed in this 3rd article in the Ceramic Defect Series. Dry forming methods generally have defects related to particle size distribution, binders, and pressing parameters. Wet processing methods have defects generated by the state of flocculation of the slip and moisture control.

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